FDA.reportPublic FDA data

VARIANT II B-thalassemia

Primary DI
00847817009204
Brand
VARIANT II B-thalassemia
Company
BIO-RAD LABORATORIES, INC.
Model
270-0083
Catalog number
2700083
Device description
VARIANT II B-thalassemia Short Program Hemoglobin A2/F Calibrator/Diluent Set
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JPDHEMOGLOBIN A2 QUANTITATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPDHemoglobin A2 QuantitationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K991127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K991127000VARIANT II B-THALASSEMIABio-Rad1999-06-10JPD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00847817009204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00847817009204008478170092048478170092040847817009204

GMDN Terms#

Term, Definition table
TermDefinition
Haemoglobin A2 (HbA2) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of haemoglobin subtype A2 (HbA2) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)224-6723diagcs@bio-rad.com

Regulatory Flags#

DUNS number
132528295
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847661000778Lyphochek7447442016-09-12
00847661000785Lyphochek7457452016-09-12
00847661000792Lyphochek7467462016-09-12
00847661001027Lyphochek5975972016-09-12
00847661001034Lyphochek5985982016-09-12
00847661001041Lyphochek5995992016-09-12
00847661001898Lyphochek598X598X2016-09-12
00847661001959Lyphochek745X745X2016-09-12
0361052031061896AN96AN-BPU-QUEST96AN-BPU-QUEST2016-09-12
03610520547663ANA PLATE196AN-BPU196AN-BPU2016-09-12
0361052056045796AN96AN-BPU-TRINITY96AN-BPU-TRINITY2016-09-12
03610520569184ANA PLATE196AN-BPU-ED196AN-BPU-ED2016-09-12
00847661000082Liquichek1071072016-09-12
00847661000099Liquichek1081082016-09-12
00847661000105Liquichek1111112016-09-12
00847661000112Liquichek1121122016-09-12
00847661000129Liquichek1181182016-09-12
00847661000204Liquichek1291292016-09-12
00847661000211Liquichek1311312016-09-19
00847661000228Liquichek1301302016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04560189283114TSKgel G7 β-Thal. HSiTOSOH CORPORATIONJPD2016-09-24
04560189283503G7 Beta-Thalassemia Elution Buffer KitTOSOH CORPORATIONJPD2016-09-24
04560189283664Hemoglobin F&A2 CalibratorTOSOH CORPORATIONJPD2016-09-24
04560189283671Hemoglobin F&A2 Control SetTOSOH CORPORATIONJPD2016-09-24
00847817000096D-10 DualBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817000447VARIANT II B-thalassemiaBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817000805VARIANT II B-thalassemiaBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817003301D-10BIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817003448D-10 DualBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817003455D-10 DualBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817003462D-10BIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817003509D-10 DualBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817008610VARIANT II B-thalassemiaBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817008634VARIANT II B-thalassemiaBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817009914VARIANT II B-thalassemiaBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817010606Whole Blood PrimerBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817012273VARIANT II / VARIANT II TURBOBIO-RAD LABORATORIES, INC.JPD2016-09-12
00847817012303VARIANT II B-thalassemiaBIO-RAD LABORATORIES, INC.JPD2016-09-12
M52553340Sickle-Thal Quik Column KitHELENA LABORATORIES CORPORATIONJPD2016-09-07
M52553410Beta-Thal HbA2 Quik Column KitHELENA LABORATORIES CORPORATIONJPD2016-09-07